U. S. Food and Drug Administration
FDA Fact Sheet
April 27, 1998

FDA's Dietary Supplement Proposal

FDA's proposal, "Regulations on Statements made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body," to be published in the Federal Register, clarifies for manufacturers what types of claims they may -- and may not -- use on labels of dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994.

Clarification is provided by defining the term "disease" for the purpose of a dietary supplement label claim, and by describing what constitutes a disease claim, which DSHEA prohibits, as opposed to a structure/function claim, which it allows.

Relying on standard medical and legal usage, FDA's proposal defines "disease" as "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by a characteristic set of one of more signs or symptoms, including laboratory or clinical measurements, that are characteristic of a disease."

The proposal, which is generally consistent with guidance provided by the Commission on Dietary Supplement Labels (see separate fact sheet), describes allowable claims as truthful and nonmisleading statements of effect on a body system, organ, or function, provided that the context in which the claim appears does not suggest that the product treats, prevents, or mitigates a disease.

Under DSHEA, structure/function claims that meet these criteria may be used by the manufacturer without prior authorization by FDA.

The law, however, prohibits express or implicit claims that a dietary supplement has an effect on an identifiable disease, or a class of diseases.

The agency recognizes that because most disease treatments can be described in terms of their effects on a structure or function of the body, it is sometimes difficult to distinguish between allowable structure/function claims and prohibited disease claims.

The proposal therefore describes and provides numerous examples of the various types of prohibited disease claims, and when appropriate, contrasts them with examples of structure/function statements that are allowable. Under the proposal, prohibited disease claims are statements that imply or state that:

• the product has an effect on a specific disease or class of diseases. Examples of prohibited statements: "protects against the development of cancer," "reduces the pain and stiffness associated with arthritis." Examples of allowable structure/function claims (no reference to a disease): "helps promote urinary tract health," "helps maintain cardiovascular function," "promotes relaxation."

• the product is in a drug class that is intended to be used to diagnose, mitigate, treat, cure, or prevent a disease. Examples of prohibited claims include description of the product as an "antibiotic," "antiseptic," "antidepressant," or a "laxative," "vaccine," or "diuretic." Examples of allowable product descriptions (no reference to disease treatment or prevention): an "energizer," a "rejuvenative."

• the product has an effect on one or more recognizable signs or symptoms that are recognizable to health professionals or consumers as being characteristic of a specific disease or diseases. Examples of prohibited claims: "lowers cholesterol," or "reduces joint pain." Examples of allowable claims (symptoms do not identify a disease): "reduces stress and frustration," "improves absentmindedness."

• the product is a substitute for, or augmentation of, a drug or other medical therapy. Examples of prohibited claims: product names such as "Herbal Prozac," or a suggestion that the product should be used "as part of your diet when taking insulin to help maintain a healthy blood sugar level."

• the product has a role in the body's response to a disease or carrier of disease. Examples of prohibited claims: "supports the body's antiviral capabilities," "supports the body's ability to resist infection." Example of an allowable claim (effect on a normal body function): "supports the immune system."

• the product has an effect on a consequence of a natural state that presents characteristic signs or symptoms recognizable as constituting an abnormality of the body. Examples of prohibited claims: "treats toxemia of pregnancy," or affects such abnormalities associated with aging as "decreased sexual function," "hot flashes," and "Alzheimer's disease."

• the product treats, prevents or mitigates adverse events associated with a medical therapy or procedure. Examples of prohibited claims: "helps avoid diarrhea associated with antibiotic use," "reduces nausea associated with chemotherapy." Example of an allowable claim (no mention of a therapy or procedure): "helps maintain healthy intestinal flora."

• the product has an effect on a disease, made in one or more of the following ways:

  * The name of the product. Examples of prohibited product name: "Carpaltum" (implies effect on carpal tunnel syndrome), "Raynaudin" (Raynaud's phenomenon) or "Hepatacure" (liver problems). Examples of allowable product names: "Cardiohealth," "Heart Tabs."

  * Statements about the formulation of the product, including the claim that the product contains an ingredient that is a *well-known regulated drug, such as aspirin, laetrile or digoxin.

  * Citation of a publication in which the title refers to a disease use. Example of a prohibited claim for vitamin E: reference to an article entitled "Serial Coronary Angiographic Evidence That Antioxidant Vitamin Intake Reduces Progression of Coronary Artery Atherosclerosis."

  * Use of the term "disease" or "diseased."

  * Suggestions of an effect on disease through pictures, vignettes, symbols and other means.

Since the passage of DSHEA, FDA has received approximately 2,300 notifications from manufacturers about structure/function claims for their products. The agency has informed the manufacturers that about 150 of these claims are problematic, and it estimates that another 60 claims would not be permitted under the proposed criteria.

If the proposed rule becomes final, unacceptable structure/function claims will have to be removed from labeling, or the product will have to be approved as a drug under the Federal Food, Drug and Cosmetic Act.

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